MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COAGUCHEK ® XS SYSTEM; PROTHROMBIN TIME MONITOR

Catalog Number 03666794001

Device Problem Image Display Error/Artifact (1304)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2023

Event Type  malfunction  

Event Description

We received an allegation of a display issue with a coaguchek xs meter.The reporter stated that on (b)(6) 2023 or (b)(6) 2023, the meter result was 2.9 inr but the meter result was difficult to read as the screen was flickering and the display was going from dark to light.The meter now would not power on at all even after the batteries were changed.The meter result was reported to the doctor.On troubleshooting, a display or memory check could not be performed because the meter would not power on at all.The therapeutic range is 2.5 to 3.5 inr.The reporter stated that his doctor likes his inr to be at 2.9 to 3.1 inr.

Manufacturer Narrative

The meter was requested for investigation and a replacement meter was sent to the customer.E3 - occupation: patient/consumer.

Manufacturer Narrative

The product was not received for investigation.Product labeling states "if your display is not functioning properly, do not perform further tests as results may be misread if a segment is missing.Contact the roche customer support center at 1-800-428-4674 in this case.".

• Brand Name: COAGUCHEK ® XS SYSTEM
• Type of Device: PROTHROMBIN TIME MONITOR
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16962320
• MDR Text Key: 315564689
• Report Number: 1823260-2023-01690
• Device Sequence Number: 1
• Product Code: GJS
• UDI-Device Identifier: 04015630945689
• UDI-Public: 04015630945689
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062925
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 03666794001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1